Validated IFUs must be essential weapons against infections

Let me start by complimenting Healthcare Purchasing News on the excellent cover on the March HPN issue, “IFUs: Essential weapons against infections.” Let me also compliment Kara Nadeau on her extensive and informative article, “IFUs poised for standards evolution, revolution.”

My question is why you didn’t include the word “Validated” before IFUs on the HPN cover so that the cover read, “Validated IFUs: Essential weapons against infections.” I ask this important question for several reasons:

First, there have been numerous patient deaths over the past few years attributed to endoscopes whose cleaning IFUs had not been validated. As a result of these patient deaths, last summer the FDA cited Pentax and Fujifilm for failing to make sure theirinstructions for cleaning the scopes were valid.

Second, the FDA issued new guidelines last March that specifically require medical device manufactures to “validate”their cleaning IFUs. On page 22 of the FDA publication, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff,” the third paragraph states, “For class II and class III devices and select class I devices, manufacturers must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses, 21 CFR 820.30(g). Manufacturers must also establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, 21 CFR 820.75(b). Establishing procedures includes implementation, 21 CFR 820.3(k).

FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.

Third, there are now several lawsuits, most notably at Lutheran General Hospital in Park Ridge, IL, where the hospital is being sued by a deceased patient’s family for using an endoscope (Pentax) whose cleaning IFUs had not been validated. Over 38 patients became infected with CRE at Lutheran General from contaminated scopes. This tragic story points out why the FDA, AAMI, Joint Commission, AORN and the CDC are ALL pushing for the validation of manufacturers’ cleaning IFUs. As this case tragically demonstrates, following a manufacturers’ IFUs that have not been validated does not ensure against patient harm.

Fourth, while following a manufacturer’s cleaning IFUs is always a good idea (as Kara’s article points out), if the manufacturer’s IFUs have not been validated using AAMI and ANSI validation protocols, there is no way to ensure clean, sterile, moisture-free instruments on every reprocessing cycle. The documented patient harm caused by devices whose IFUs had not been validated at facilities like Lutheran General and Virginia Mason in Seattle is just the tip of the iceberg. According to the CDC, over 30,000 patients die annually from surgical infections. Many of these deadly infections are caused by contaminated instruments whose cleaning IFUs have never been validated.

Fifth, as the recent headlines over patient deaths have made it all too clear, a lack of validated cleaning IFUs is a tremendous safety issue. Healthcare facilities have a legal, ethical, financial and moral obligation to use only instruments whose IFUs have been validated. As Kara’s article points out, IFUs are indeed poised for evolution and revolution. In order to reduce patient risk and patient harm from contaminated devices, the “revolution” must include “validated” cleaning IFUs from every device manufacturer.

Best,

Jim Schneiter
America’s MedSource Inc.
[email protected]

[Editor’s Note: Jim Schneiter started his healthcare career in 1974 at American Hospital Supply Corp. In 1986, Schneiter launched America’s MedSource Inc., which develops, patents and then licenses healthcare devices and products to various companies in the industry. Schneiter holds numerous U.S. and foreign patents, patent applications, trademarks and copyrights for medical devices he has invented and developed. Additionally, he has been involved in numerous IDE filings, FDA product approvals, hospital and office-based clinical trials, 510(k) filings and independent laboratory studies.]

Hi Jim,

Thanks for writing and for being such a loyal reader of Healthcare Purchasing News.

You make some valid points. Kara Nadeau quoted the venerable Charles Hughes on p. 22 referring to “validated IFUs.” On page 24, Marcia Frieze reinforces the issue as well, and in the first paragraph under the subhead “Sticking to Standards,” Kara references AAMI and AORN guidelines.

But the REAL issue here in my opinion remains a boondoggle because it’s one of accountability and responsibility… and not in a way you might think. Yes, providers have a responsibility to use “validated” IFUs and device manufacturers have a responsibility to issue “validated” IFUs for their devices to be reprocessed, and the reprocessing equipment manufacturers have a responsibility to “validate” that their technologies actually achieve the kill rates (from disinfection to high-level disinfection to sterilization) they claim. But the enduring question is WHO is the FINAL authority qualified – and willing to accept responsibility – for declaring these claims have been validated?

The FDA? Unfortunately, the FDA relies on paperwork submitted by manufacturers themselves, and to the best of my knowledge, doesn’t have or employ [Underwriters Laboratories]-type labs and other resources to test and verify claims. The federal agency just checks over paperwork submitted to “clear” something for marketing and technically doesn’t “approve” products for use. If FDA were more involved directly, then it would be subject to lawsuits involving negligence. When the FDA calls for “validated” IFUs and the manufacturers only provide IFUs without evidence of validation by some FDA-accepted/certified validation organization does the federal agency prevent the devices from going to market? Well, if they did we would not be writing and publishing stories like this, and patients (and their families and friends) wouldn’t be suffering.

Further, by reprocessing these devices providers have been tagged as “remanufacturers,” which can place them in a similar boat as the manufacturers themselves, but the FDA hasn’t shut down SPD departments where questionable practices led to the incidents cited in the HPN article and others.

AAMI and/or AORN? These two organizations issue “guidelines” and “recommended practices” that protect them from legal recrimination and financial restitution.

Ultimately, the healthcare industry voluntarily must agree to follow some certification/validation-granting body – Joint Commission perhaps? – that might subcontract actual scientific testing to an Underwriters Laboratories-like organization. Then the FDA would have to agree that the Joint Commission, for example, is the certifying/validating body of record. Furthermore, if suppliers and providers alike are found to be operating in violation of the certified/validated IFUs as determined by the universally accepted governing body and “approved” by the FDA then another government agency – as in CMS – could deny reimbursement to those providers for non-compliance and violations (which would be in addition to the suppliers and providers being subjected to operational malpractice lawsuits stemming from patient harm).

Once again, it all comes down to standards. Who sets them? Who agrees to them? How do you make them stick? How do you enforce compliance?

Thanks for reading and sharing your thoughts. We now have fodder for future coverage and stories.

RDB

Hello Rick,

Thank you for your lengthy, thoughtful response to my email. Let me address the points you made in the order in which you made them:

You are correct that the word “validated” was referenced in Kara’s article. My point in suggesting it be included in the title on the HPN cover was to reinforce the tremendous value of validated IFUs vs. non-validated IFUs when it comes to ensuring clean, sterile, moisture-free instruments for every patient, every time to reduce patient risk/harm.

1. Your point about who is the final authority (and willing to accept responsibility) for declaring that a manufacturer’s IFUs have been properly validated is an excellent one. If you look to the FDA’s citing of Pentax and Fujifilm last August for not having validated their cleaning IFUs for their endoscopes, it would appear that the FDA is finally stepping up to the plate and assuming responsibility for enforcing their call for validation first issued back in 2013.
2. By way of history, in 2011 AAMI and the FDA hosted two, two-day long “Reprocessing Summits” at the FDA’s facility in Maryland. I attended both of those meeting (one in June and the other one in November) and served on a discussion panel concerning the design of medical devices to improve decontamination and “cleanability.” During the four days of those two meetings, the topic of validation of cleaning IFUs came up on multiple occasions.When questioned by an audience member during the meeting, the FDA admitted that they had never required device manufacturers to validate their IFUs. As an outgrowth of that meeting, the FDA changed the requirements for submission of a 510(k). Starting in 2013, the FDA now requires a device manufacturer to include an independently validated cleaning IFU with their 510(k) submission for a new surgical instrument. This more evidence of the FDA taking ownership of this important patient safety issue.During that same meeting in 2011 the FDA was also questioned as to whether they would require the device manufacturers to go back and validate their cleaning IFUs on all of the devices that were already in the market. The FDA said that they had no plans to do so. Like most people in the audience, I was very disappointed with their response.As a reference, there are two documents that summarized the collective recommendations of those AAMI/FDA meetings.
   • Reprocessing: 2011 Summit. Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit
   • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – Guidance for Industry and Food and Drug Administration Staff

1. When it comes to SPD departments, the FDA is not going to try and regulate them even though they are considered to be “remanufacturers” from a regulatory standpoint. Unless Congress gives the FDA authorization to do so (and I don’t see that happening), the FDA will not be regulating SPD departments anytime soon.SPD departments will however come under ever-increasing scrutiny by hospital administration as a result of lawsuits, such as the one against Lutheran General in Park Ridge. I know that hospital Risk Managers and C-Suite executives will become more involved in the management and practices of their SPD departments in order to minimize the risk of legal action caused by patient harm from a contaminated instrument/device.
2. Like you, I have long felt that we need some type of independent certification/validation granting authority. The Joint Commission might be a good starting point. Withholding reimbursement by CMS would also be an effective way to enforce compliance, much like “Never Events” legislation was designed to do.I believe that the more immediate, cost-effective solution lies with SPD Managers and Risk Management personnel challenging their current suppliers to provide independently validated IFUs for their products. When asking their current suppliers for validated IFUs, they must be sure that the manufacturer understands that they are asking for more than just cleaning instructions (IFUs). The manufacturer must have – and provide – independent laboratory verification that their cleaning IFUs actually work for cleaning the instrument. If the manufacturer cannot – or will not – provide validated IFUs, then the hospital should give serious consideration to switching to manufacturers that can – and will – provide independently validated IFUs for their products. The infection preventionist can support SPD and Risk Management by exploring the moral, legal, ethical and financial liability issues associated with using instruments whose IFUs have not been validated.

At the end of the day, it really gets down to a simple issue: Reducing patient risk/harm caused by devices that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize. Without independent validation of a device’s cleaning IFUs, SPD personnel do not have the ability to ensure clean, sterile, moisture-free instruments for every patient.

Best,

Jim

Hi Jim,

I will reinforce the idea of IFU validation in my Fast Foreward column. Further I will suggest that there needs to be an independent body to validate all of the IFUs – as a condition of 510(k) or PMA clearance. I’m thinking Underwriters Laboratories and/or ECRI Institute and/or some other similar types of operations that actually set up divisions to do the work.

Nothing like stirring the pot, which I’m more than happy to do.

Thanks again for writing, sharing your viewpoint and for your dedicated career in the industry.

RDB

Hello Rick,

I am glad to hear that when it comes to validating IFUs you find this issue salient. More than just being salient, let me suggest that non-validated IFUs is an issue that impacts patient morbidity and mortality every day in hospitals throughout the country. As you know, according to the CDC, over 30,000 patients die annually from surgical infections. A lot of those infections are caused by contaminated instruments whose IFUs have never been validated.

I’m very pleased that you are going to reinforce the idea of requiring manufacturers to validate their cleaning IFUs. As you know, the CRE outbreak and resulting patient harm at Lutheran General and Virginia Mason were caused by contaminated devices where their IFUs had never been validated.

I couldn’t agree more that the industry needs an independent body to validate every manufacturer’s cleaning IFUs. Your suggestion that the industry use Underwriters Laboratories or ECRI is a good idea. However, I would strongly recommend Nelson Laboratories in Salt Lake City. Hundreds of medical device companies have been utilizing Nelson Labs for validating their devices’ cleaning IFUs for several decades. The reason so many companies utilize Nelson Labs is because they’ve been utilizing industry recognized AAMI validation testing protocols for years. Additionally, every hospital in the country is familiar with Nelson Laboratories and their reports so they bring instant credibility to the table. I’ve known these folks and their work for 25+ years and they would be my first choice given their demonstrated industry expertise, testing facilities and staff.

[Editor’s Note: Neither Jim Schneiter nor Rick Barlow have any financial interest in Nelson Laboratories, Underwriters Laboratories or ECRI Institute. Further, after this email exchange took place Nelson Laboratories, “a domestic provider of life cycle microbiology testing services for the medical devices, pharmaceutical and tissue industries,” was acquired by Sterigenics International LLC, “a global provider of contract sterilization, gamma technologies and medical isotopes.”]

Let me also suggest that in your column you reinforce the fact that Purchasing, SPD, Infection Prevention, Risk Management and Operating Room personnel must demandthat their manufacturers/suppliers provide them with validated cleaning IFUs for their devices. Given that the FDA is not going to make the manufacturers go back and validate the IFUs for all of the products that they currently sell, the responsibility, obligation and duty for protecting patients falls directly on hospital personnel.

My friend Dennis Maki, M.D., retired head of the Infectious Diseases Department at the University of Wisconsin Medical School, always used to say, “When sales representatives make claims about how well their product works, ask to see their documentation – clinicals, independent laboratory testing, etc. If the manufacturer can’t document its claims, why would you use that product with your patients?”

I’m really glad that you are “stirring the pot” on this vitally important topic!

Best,

Jim

Jim,

Please correct me if I’m wrong, but to the best of my knowledge the FDA does not require hospital SPD departments to validate IFUs but to use “validated” IFUs. Further, the FDA may require device manufacturers to validate their IFUs, but the FDA does not have an “approved list” of validation labs and only relies on paperwork submitted by the device manufacturers.

Therein lays the problem and my argument. The FDA went off on third-party reprocessing companies that SPDs used for reuse of single-use devices (another hornet’s nest of an issue you’ll agree).

My problem is that the FDA may specify IFU validation without providing instructions on how to obtain that validation and whether the obtained validation is effective and proper. Hospital SPDs merely follow what manufacturers tell them (cutting corners and taking shortcuts when stressful times warrant such last-minute “crisis-averting” decisions). What’s not clear is how device manufacturers validate their IFUs or have those IFUs validated.

If I’m off-base, please let me know. Otherwise, that’s the square peg I’m pounding into a round hole. Thanks again.

RDB

Hello Rick –

At present, the FDA does not require hospitals to only use products that have validated IFUs. The lack of an FDA requirement does not however remove the legal liability that a hospital faces if they use products without validated IFUs. Specifically, in the Lutheran General case, the hospital is being sued for using a product (Pentax endoscopes) without validated IFUs.

Only recently did the FDA start to require that the manufactures submit validated IFUs with new product 510(k) submissions. As such, the vast majority of products in daily use in hospitals do not have validated IFUs. As you know, the lack of validated cleaning IFUs can lead to patient harm and patient death.

In terms of the FDA and their requirements for the validation of IFUs on new product submissions, they have very specific requirements that the manufacture must meet. In my earlier email to you I cited the FDA requirement document and quoted one of the key paragraphs.

The FDA does not ‘validate’ testing laboratories. However, since 2013, reusable device manufacturers must provide validated test results from an independent laboratory that comply with the FDA’s requirements when submitting a 510(k) for a new device.

Hospitals, clinicians and patients all expect clean, sterile, moisture-free instruments after every reprocessing cycle. Regretfully, in the absence of validated IFUs, that does not always happen resulting in patient morbidity and mortality caused by contaminated instruments.

The only long-term solution is an FDA requirement that all IFUs be validated using AAMI and ANSI testing protocols. Unless – and until – the FDA makes this a requirement for all reusable instruments that are already in the market, we will continue to harm patients with instruments that are difficult, if not impossible, to thoroughly decontaminate, clean and sterilize.

The only short-term solution is for SPD personnel to demand validated IFUs from their current suppliers!Hospitals can avoid unnecessary patient harm by utilizing reusable instruments with validated IFUs. As I stated in my initial email to you, validated IFUs are the key to infection prevention due to contaminated instruments. Without validated IFUs, a surgeon has no way of knowing if the instrument they are placing into their patient is as clean on the inside as it is on the outside.

We need to include Supply Chain in this campaign, too.

Specifically, Supply Chain can include in their new vendor qualification checklist the need for validated IFUs. For their existing vendors, they can immediately launch a campaign to request that their vendors provide validated IFUs on their instruments. If a current vendor cannot, or will not, provide validated IFUs for their instruments, then the hospital should give serious consideration to switching to vendors that will provide validated IFUs for their instruments.

In addition to involving purchasing at the hospital level, group purchasing organizations (GPOs) should lead the charge as well. Given their national negotiating power, there is no reason for GPOs to continue to award contracts to instrument manufacturers who cannot, or will not validate their cleaning IFUs.

Best,

Jim

Editor’s Note: If you would like to contribute your insights to this issue, please go to the HPN Blogline and share your thoughts athttp://hpnonline.blogspot.com/2016/04/the-v-word.html